Reported Nov 15, 2023 · Ongoing
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation…
Medtronic Navigation, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 200 Medtronic Drive · Lafayette, CO · 80026
Is this the product you have?
- StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
- Lot codes and dates
- Model Number9735762
- UDI-DI Code00763000532123 Software Versions 2.0 and 2.0.1 All systems with the impacted software version regardless of how it was purchased Updated list of Product Models/Serial provide on 06/06/2024 and was uploaded to Associated Documents
- Amount recalled
- 5,240 affected systems
Where it was sold
Why it was recalled
Stop using this product now
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
Using this product could cause serious injury, illness or death — stop using it now.
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